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In-vitro diagnostics

21
Apr 2023

The revised EBM catalog came into force in Germany in April 2023

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.
07
Apr 2023

Med Tech-related technology assessments and clinical guidelines from NICE in March 2023

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.
22
Mar 2023

A new screening algorithm for preeclampsia will be covered in a clinical study setting in Norway

A new preeclampsia screening algorithm has been evaluated within the "New Method" framework since 2021. The algorithm helps to predict the risk of preeclampsia in the first trimester based on several parameters, including ultrasound examination and measurement of the Placenta Growth Factor (PIGF). In March 2023, the Decision Forum for "New Method" was held and commissioned to perform the implementation study of a new screening algorithm at St. Olav's Hospital.
10
Mar 2023

Med Tech-related technology assessments and clinical guidelines from NICE in February 2023

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.
17
Feb 2023

Swiss List of Analyses updated in March 2023

On January 27, 2023, the Swiss Federal Office for Public Health announced the update of Annex 3 of the Health Care Benefit Ordinance (KLV/OPre), which contains the list of reimbursed IVD tests (List of Analyses). Two new tests on Monkeypox virus check will be introduced in March 2023.
15
Feb 2023

New HTAs initiated by OSTEBA in Spain in February 2023

In February 2023, it was announced that the Basque Office for Health Technology Assessment (OSTEBA) initiated several HTAs, including evaluations in the e-health, radiology, nephrology and urology, cardiovascular, IVD, obstetrics and gynecology, diagnostic imaging, radiotherapy, neurovascular, ENT, interventional radiology, surgical procedures, and some other fields.
13
Feb 2023

Reduction of reimbursement tariffs for IVD tests registered in the NABM nomenclature in France

On January 31, 2023, the Order approving Addendum 11 to the National Convention for Laboratory Directors was published in the Official Journal of the French Republic. The Addendum implements financial measures provided for by the Social Security Financing Act – reduces the reimbursement tariffs for the tests registered in the main reimbursement catalog for IVD tests in France Nomenclature of Medical Biology Acts (NABM).
31
Jan 2023

MedTech-related technology assessments and clinical guidelines from NICE in January 2023

In January 2023, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (percutaneous image-guided cryoablation of peripheral neuroma, laparoscopic insertion of a magnetic ring, transcutaneous electrical stimulation of the trigeminal nerve, and trabeculectomy with a biodegradable collagen matrix implant ), two new Diagnostic Guidance (devices for remote monitoring of Parkinson's disease, MRI-based technologies for assessing non-alcoholic fatty liver disease), and three new Medtech Innovation Briefings (PredictSURE IBD, Ambu aScope 4 Broncho, and Aquablation robotic therapy). One MedTech-related clinical guideline was updated.
20
Jan 2023

MedTech-related health technology assessments from NIHR in December 2022

In December 2022, the National Institute for Health and Care Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned laser therapy in diabetic macular oedema, EarlyCDT Lung blood test, video-assisted thoracoscopic or open lobectomy, urethral slings for stress urinary incontinence, placental growth factor (PlGF) and sFlt-1 tests, and photobiomodulation in the management of oral mucositis. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.
18
Jan 2023

2023 Pathology Activity Codes (APAT) system and reimbursement tariffs released in Norway

In January 2023, the updated Pathology Activity Codes (APAT) of the Norwegian Pathology Code system (NORPAT) came into force. Since 2022, APAT codes have been included in the new reimbursement scheme by Helfo (the Norwegian Health Economics Administration) for outpatient pathology services. Five new classified sample materials for cytology and 22 new additional codes for the method of testing were added to the scheme in 2023.